FULLERENES

CAS Number
115383-22-7
Function
Antioxidant
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes No FDA GRAS classification or specific cosmetic restriction identified. FDA issued a warning letter to Bioactive C60/FullerlifeC60 LLC (605954, dated 30 March 2020) concerning unapproved drug claims for C60 fullerene products. No formal CIR cosmetic ingredient safety assessment exists. Not classified as a sunscreen active under FDA OTC monograph rules.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Fullerenes (C60, C70) are permitted under EU law but safety cannot be established due to unresolved genotoxicity concerns, lack of toxicokinetic data, and insufficient dermal absorption characterization per SCCS Final Opinion SCCS/1649/23; hydroxylated fullerenes were assessed as genotoxic and not safe.

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Concern Level: High

Regulatory Flags

nano-form carcinogen-concern sccs-opinion eu-regulatory-risk genotoxicity-concern

Frequently Asked Questions

Is FULLERENES safe in cosmetics?

Fullerenes (C60, C70) are permitted under EU law but safety cannot be established due to unresolved genotoxicity concerns, lack of toxicokinetic data, and insufficient dermal absorption characterization per SCCS Final Opinion SCCS/1649/23; hydroxylated fullerenes were assessed as genotoxic and not safe. The EU classifies FULLERENES as "permitted". Safety rating: POOR.

Is FULLERENES allowed in the EU?

FULLERENES EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does FULLERENES do in cosmetics?

FULLERENES functions as: Antioxidant. It is classified as a Active Ingredient in our database. CAS number: 115383-22-7.

What is the Margin of Safety for FULLERENES?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

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